Individuals who are interested in learning more about complex generic drugs and the important role they play in U.S. health care are encouraged to explore the additional resources provided below.
Please note that by clicking any of the links provided below, you acknowledge that you are leaving the Center for Research on Complex Generics (CRCG) website and that CRCG is not responsible for the content available on these external websites.
FDA Guidance Documents
This website lists all official FDA Guidance Documents and other regulatory guidance. Users can search for documents using key words and narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
This website created by the U.S. Food and Drug Administration (FDA) provides a comprehensive overview of generic drugs, including resources for industry as well as patient education.
Generic Drugs Science & Research
In collaboration with industry and the public, the FDA creates an annual list of regulatory science initiatives on generic drugs. The research studies conducted under these initiatives advance public health by contributing to the development of safe and effective generic drugs.
Inactive Ingredient Database (IID)
Managed by the FDA, this webpage offers answers to some frequently asked questions about the inactive ingredients often found in generic drugs.
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information.
Product-Specific Guidances for Generic Drug Development
Information about product-specific guidances (PSGs) issued by the FDA that describe the agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs.
Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
Created by the FDA, this webpage provides information related to upcoming new and revised PSGs to support the development and approval of safe and effective complex generic drug products.